Depression and Insulin Resistance in Adolescents
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 35
- 试验地点
- 2
- 主要终点
- Homeostasis model assessment of insulin resistance
研究概览
简要总结
Type 2 diabetes is a chronic disease that puts people at risk for major health problems like heart disease. Type 2 diabetes is the most common type of diabetes in adults. However, there has been a concerning rise in type 2 diabetes among teenagers. Diabetes develops through poor insulin sensitivity, meaning that insulin - an important chemical the body makes to keep blood sugar normal - isn't working properly. Type 2 diabetes can be prevented by improving insulin sensitivity. Stress is related to insulin sensitivity. Individuals who feel stressed have worse insulin sensitivity than individuals who do not feel stressed. In adults, decreasing stress leads to improvements in insulin sensitivity, but this hasn't been tested in teenagers. The purpose of this study is to find out if taking part in a brief group program to decrease stress will improve insulin sensitivity and lower diabetes risk in teenage girls.
详细描述
After a screening to determine eligibility, girls are randomly assigned to take part in one of two 6-week group programs: 1) Learning to BREATHE - a mindfulness-based program, or 2) Colorado Blues - a cognitive-behavioral program. After the group, girls return for three follow-up visits over the course of a year. The main outcomes are depressive symptoms and insulin resistance. We also are assessing stress, eating behavior, fitness, and mindfulness.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 12 Years 至 17 Years（Child）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Age 12-17 years
- •Overweight or obese, defined as a body mass index (BMI; kg/m2) ≥ 85th percentile for age
- •Family history of type 2 diabetes or pre-diabetes in 1st degree relative (e.g., parent or sibling) or 2nd degree relative (e.g., aunt, uncle, or grandparent)
- •Elevated stress/symptoms of depression as indicated by a Center for Epidemiological Studies-Depression Scale Total Score ≥ 16
- •Good general health as reported by adolescent and parent/guardian
- •English speaking (required for adolescent only, because the groups will be conducted in English)
排除标准
- •Pregnancy
- •Current psychiatric disorder such as major depressive disorder necessitating treatment
- •Type 2 diabetes as indicated by fasting glucose > 126 mg/dL
- •Use of medication affecting insulin resistance, body weight, or mood such as anti-depressants or stimulants
- •Current psychotherapy or weight loss treatment
结局指标
主要结局
Homeostasis model assessment of insulin resistance
时间窗: 1 year
Derived from fasting insulin and glucose
次要结局
- Center for Epidemiological Studies-Depression Scale(1 year)